Integrated left atrial appendage occluder

Abstract

This invention discloses an integrated left atrial appendage occluder, comprising a sealing part and an anchoring part connected as one unit. The sealing part has one end fixedly connected to an occlusion head, and the other end integrated with the anchoring part, having a sealing tensioning part protruding from the anchoring part. The anchoring part has an anchoring convergence part at its end, and has several anchoring support beams symmetrically arranged around the central axis of the occlusion head. The anchoring support beams are provided with anchoring hooks along the direction of the delivery pipe. The left atrial appendage occluder of this invention has high reliability, safety, and sealing stability, can be repeatedly recycled, and exhibits strong flexibility in the vertical direction and circumferential sealing flexibility, better meeting the clinical needs for left atrial fibrillation (AF).

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of left atrial appendage occluder, in particular to an integrated left atrial appendage occluder. BACKGROUND

[0002] Atrial fibrillation (AF) is the most common sustained arrhythmia in clinical practice, and the incidence of AF in the general population is 0.5% to 1.3%. The most important harm of AF is to promote thrombosis, and thrombus embolization leads to complications such as stroke and peripheral vascular embolism, which significantly increases the disability rate and mortality. Stroke is the most common and most harmful complication of AF, and about 150 million people worldwide suffer from stroke every year, of which 20% to 25% are attributed to AF. Studies have shown that 60% of thrombosis in patients with rheumatic heart disease and atrial fibrillation comes from the left atrial appendage, and more than 90% of thrombosis in non-valvular atrial fibrillation patients occurs in the left atrial appendage. Therefore, intervention in the left atrial appendage to prevent thromboembolism, especially stroke, has important theoretical basis and clinical significance in patients with atrial fibrillation.

[0003] The current clinical methods for preventing ischemic stroke in atrial fibrillation patients mainly include three methods. The first method is to take anticoagulant drugs such as warfarin, but the application of warfarin has certain risk of bleeding, and frequent monitoring is required, and there are many contraindications, so the clinical application is relatively difficult; the second method is to directly remove or ligate the atrial appendage during cardiac surgery, and the main disadvantage of this method is that the complete closure rate of the left atrial appendage is low, and previous studies have shown that the success rate of complete removal of the left atrial appendage is about 80%, and there is a risk of tearing and bleeding. The third method is through interventional therapy, i.e. occlusion product. The principle of action is that the left atrial appendage occluder closes the left atrial appendage of the left atrial appendage, blocks the blood flow between the left atrial appendage and the left atrium, prevents the thrombus generated by the left atrial appendage from entering the atrium, and reduces the risk of stroke. After a period of time, the surface of the occlusion device is endothelialized, which can completely solve the problem of thrombus entering the left atrium from the left atrial appendage.

[0004] The structure of the left atrial appendage occluder on the market at present mainly includes two types. One is the double-disc structure represented by Abbott's ACP, which is usually composed of a sealing part and an anchoring part. The sealing part occludes the opening position of the left atrial appendage after release, and the anchoring part is released inside the left atrial appendage and has barbs, which serves to fix the sealing part. The sealing part of the left atrial appendage occluder after release needs to be closely attached to the opening position of the left atrial appendage to occlude the left atrial appendage, but the double-disc structure product also has defects: 1. The left atrial appendage occluder with double-disc structure is a composite integrated type, and the sealing part and the anchoring part cannot deform completely independently. When the anchoring part is inserted into the left atrial appendage, its shape needs to conform to the internal structure of the left atrial appendage. Thus, when the sealing part is buckled at the opening of the left atrial appendage, it will be pulled by the anchoring part, so that the disc part cannot fully adhere to the opening of the left atrial appendage, making it difficult to achieve the best occlusion effect. 2. The resistance is large during use. The anchoring part of the existing left atrial appendage occluder with double-disc structure is generally woven into a mesh structure. Since the wire used in the weaving process will have some overlapping and crossing, the resistance will increase, so the size of the delivery sheath required by the woven mesh structure of the anchoring part will be larger than that of the cutting structure under the same conditions. 3. The processing technology is complex, and it needs to be woven and manually sewn, which cannot be laser integrated cutting.

[0005] The other is the plug structure represented by Watchman of Boston Scientific, which makes the product into a plug with a flow-blocking film in the shape of a ball, cylinder or cone. The plug has a certain elasticity and can deform in the left atrial appendage to adapt to the shape of the left atrial appendage cavity, so as to achieve the purpose of filling the left atrial appendage, and the flow-blocking film on the plug can block the blood flow. At present, Watchman occluder has the largest market share in the domestic market. However, the plug structure product also has certain defects: 1. The stability of Watchman left atrial appendage occluder is poor. Since the anatomical structure of human left atrial appendage has various shapes such as oval and peanut shape, and also has multiple cavities, the plug type left atrial appendage occluder cannot completely occlude all left atrial appendages. 2. It is difficult to recover. Although the barb of Watchman left atrial appendage occluder has enough puncture force, it hinders the recovery of the occluder and cannot realize repeated positioning. 3. Watchman left atrial appendage occluder is easy to stab the tissue. The plug structure is usually designed as an open type at the distal end, and the sharp part at the distal end is easy to stab the left atrial appendage, causing pericardial tamponade. 4. In addition, the left atrial appendage occluder has the problem of insufficient strength.

[0006] Overall, the existing left atrial appendage occluder has some shortcomings in stability, recoverability and strength. SUMMARY

[0007] In order to overcome the above deficiencies of the prior art, the present application provides an integrated left atrial appendage occluder which integrates a split structure into a one-piece structure, solves the problems of easy falling of the connecting piece of the split structure and easy residual leakage and insufficient anchoring of the one-piece structure.

[0008] The technical scheme adopted by the present application is as follows: an integrated left atrial appendage occluder comprises a sealing part and an anchoring part which are connected into one piece, wherein:

[0009] The sealing part is fixedly connected to the occlusion head at one end and is integrally formed with the anchoring part at the other end, and has a sealing tension part which protrudes from the anchoring part;

[0010] The anchoring part has an anchoring folding part at the end, and has a plurality of anchoring support beams which are symmetrically arranged with the center axis of the occlusion head as the center line;

[0011] The anchoring support beams are provided with anchoring barbs in the direction of the delivery tube.

[0012] Preferably, the sealing part comprises a fixed connection part, a sealing pre-bending part and a sealing tension part which are arranged in sequence from the occlusion head.

[0013] Preferably,

[0014] The sealing tension part is formed by a plurality of sealing units which are arranged in a circle along the outside of the center axis of the occlusion head;

[0015] And each of the sealing units is bifurcated into at least one sealing bending and lifting part sealing bending and lifting part one and sealing bending and lifting part two from the tail of the sealing pre-bending part to both sides thereof;

[0016] The at least two sealing bending and lifting parts sealing bending and lifting part one and sealing bending and lifting part two are respectively lifted towards the occlusion head, and then protrude outward by a distance from the center axis of the occlusion head and are bent inward again to form at least sealing bending muscles sealing bending muscle one and sealing bending muscle two;

[0017] The plurality of sealing bending muscles sealing bending muscle one and sealing bending muscle two are bent towards the center axis of the occlusion head and are folded, and finally converge on one anchoring support beam.

[0018] Preferably, the sealing bending and lifting part one of each of the sealing units has one branch on one side which converges with one branch on one side of the sealing bending and lifting part two of the sealing unit adjacent thereto at the top position of the sealing unit;

[0019] And the other branch on the other side converges with one branch on one side of the sealing bending and lifting part of the other sealing unit adjacent thereto at the top position of the sealing unit.

[0020] Preferably, the sealing bent ribs of the sealing units are bent towards the center axis of the plugging head and the retracted portions form an anchoring top beam in the circumferential direction;

[0021] The width H in the height direction of the anchoring top beam is reduced to improve the overall flexibility of the left atrial appendage plugging device.

[0022] Preferably, each of the anchoring support beams is bifurcated to form at least two bifurcated bent portions on the left and right sides in the circumferential direction near one end of the retracted portion.

[0023] Each of the bifurcated bent portions, the bifurcated bent portion one and the bifurcated bent portion two, converges at an anchoring support point, and the anchoring support portion is bent inward in the axial direction and towards the plugging head to form an anchoring retracted portion.

[0024] Preferably, the top of each anchoring support portion is provided with an anchoring barb in the reverse delivery tube direction, which can enhance the positioning function of the entire anchoring portion, be recycled multiple times, have good flexibility, improve the anchoring of the plugging device in the left atrial appendage, and prevent the occurrence of falling phenomenon.

[0025] Preferably, the end of the anchoring retracted portion is fixed as a whole by inlay welding.

[0026] Preferably, the bifurcated bent portion one and the bifurcated bent portion two of the anchoring support beams form an anchoring bottom beam in the circumferential direction, and the width H in the height direction of the anchoring bottom beam is reduced to improve the overall flexibility of the left atrial appendage plugging device.

[0027] Preferably, the anchoring barb in the forward delivery tube direction is a cross-shaped double barb structure.

[0028] Preferably, the anchoring support beams are spiral structures.

[0029] Compared with the prior art, the present application has the following advantages:

[0030] 1. The device is of an integrated structure, which is formed by laser cutting and heat treatment of a nickel-titanium alloy pipe, has a waist structure like a split structure, avoids the falling problem of connecting parts, and has greater reliability, safety, and sealing stability.

[0031] 2. The barb has two different forms, one is good in recyclability, and one is better in anchoring, the two barbs cooperate with each other to greatly improve the stability of the occluder. The barb in the prior art is a cross-shaped barb, which is not in the same plane as the adjacent rod when laser cutting, cutting is very difficult, and the structure of the left atrial appendage occluder in the prior art is very complex, and the corresponding nickel-titanium pipe material diameter is larger, which is not conducive to the delivery of the occluder in the operation. The barb of the present patent is in the same plane as the adjacent rod when expanded into a cutting plan view, and occupies a small space, and the required nickel-titanium pipe material diameter is also very small, which is conducive to the delivery of the left atrial appendage occluder;

[0032] 3. The anchor support beam is a spiral structure, which is conducive to improving the flexibility of the occluder in the up-down direction, and can adapt to various shapes of left atrial appendage structure, and has better adaptability.

[0033] In summary, the integrated left atrial appendage occluder has high reliability, safety and sealing stability, can be recycled repeatedly, and has high flexibility in the up-down direction of the occluder and in the circumferential direction, and can better meet the clinical use requirements of left atrial fibrillation (atrial fibrillation). BRIEF DESCRIPTION OF DRAWINGS

[0034] Figure 1 is a structure diagram of an embodiment of the integrated left atrial appendage occluder;

[0035] Figure 2 is a three-dimensional structure diagram of the embodiment of Figure 1

[0036] Figure 3 is a top view of the embodiment of Figure 1

[0037] Figure 4 is a structure diagram of the sealing unit 231;

[0038] Figure 5 is a structure diagram of an embodiment of the integrated left atrial appendage occluder without welding inserts;

[0039] Figure 6 is a structure diagram of another embodiment of the integrated left atrial appendage occluder;

[0040] Figure 7 is a top view of the embodiment of Figure 6

[0041] Figure 8 is a structure diagram of an embodiment of the integrated left atrial appendage occluder with a spiral anchor support beam;

[0042] ​​​Wherein: 10 - plugging head, 20 - sealing part, 21 - fixed connection part, 22 - sealing pre-bending part, 23 - sealing tensioning part, 231 - sealing unit, 2311 - sealing bending lifting part one, 2312 - sealing bending lifting part two, 2313 - sealing bending rib one, 2314 - sealing bending rib two; 30 - anchoring part, 31 - anchoring support beam, 32 - bifurcated bending part one, 33 - bifurcated bending part two, 34 - anchoring support point, 35 - anchoring support part, 36 - anchoring folding part, 37 - anchoring barb in the opposite direction of the conveying pipe, 38 - anchoring barb in the conveying pipe direction, 39 - inlay block;

[0043] 40 - anchoring top cross beam, 50 - anchoring bottom cross beam. DETAILED DESCRIPTION

[0044] The embodiments of the present application will be described in detail below, examples of which are shown in the drawings, wherein the same or similar notations represent the same or similar elements or elements having the same or similar functions throughout. The embodiments described below by referring to the drawings are exemplary only, for the purpose of explaining the present application, and should not be understood as a limitation of the present application.

[0045] In the description of the present application, it should be understood that the terms "center", "upper", "lower", "front", "back", "left", "right" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the purpose of facilitating the description of the present application and simplifying the description, and do not indicate or imply that the indicated combination or element must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation of the present application. In addition, during the description of the embodiments of the present application, the "upper", "lower", "front", "back", "left", "right" and the like of the devices in all the drawings are based on the standard shown in the drawings. Figure 1

[0046] As shown in Figure 1 and Figure 5 , Figure 6 , the one-piece left atrial appendage plugging device comprises a sealing part 20 and an anchoring part 30 connected as one body, wherein:

[0047] The sealing part 20 is fixedly connected to the plugging head 10 at one end and integrally formed with the anchoring part 30 at the other end, and has a sealing tensioning part 23 protruding from the anchoring part 30;

[0048] ​The anchor part 30 has an anchor converging part 36 at the end, and a plurality of anchor support beams 31 which are symmetrical to the center axis of the occluder as the center line. The presence of the anchor support beam 31 can make the left atrial appendage occluder symmetrical to the center axis of the occluder at the ostium of the left atrial appendage, ensure better shrinkage performance when shrinking, and adapt to different shapes and shrinkage requirements of the left atrial appendage structure, thereby improving the sealing effect of the occlusion and reducing residual shunt. The end converging and fixing has better flexible deformation ability and can better ensure better recovery ability after deformation.

[0049] The anchor support beam 31 is provided with anchor barbs 38 in the direction of the delivery tube for anchoring. The anchor barbs 38 in the direction of the delivery tube at this position can be recycled multiple times and have good flexibility.

[0050] For details Figure 1 As shown, the sealing part 20 includes a fixed connection part 21, a sealing pre-bending part 22 and a sealing tensioning part 23 arranged in sequence from the occluder 10. The sealing pre-bending part 22 and the sealing tensioning part 23 of this structure are continuously bent, which improves the flexibility of the entire sealing part and enhances the anti-flexible deformation ability, ensuring good use performance and stability of the left atrial appendage occluder.

[0051] Referring to Figure 1 and Figure 4 As shown, the sealing tensioning part 23 is formed by a plurality of sealing units 231 arranged in a circle along the outside of the center axis of the occluder.

[0052] And each of the sealing units 231, from the tail of the sealing pre-bending part 22, is forked into at least two sealing bending up parts (2311, 2312), as shown in the figure, which are forked into two sealing bending up parts 2311 and 2312.

[0053] From Figure 1 and Figure 2 , Figure 3 As can be seen, the sealing bending up part 2311 and the sealing bending up part 2312 are respectively bent up to the occluder, and then protrude outward from the center axis of the occluder by a distance and then bend inward to the center axis of the occluder to form at least two sealing bending muscles, i.e. sealing bending muscle 2313 and sealing bending muscle 2314, which can also be a plurality of sealing bending muscles (but at least one sealing bending muscle on one side is required).

[0054] The at least two sealing bending ribs (sealing bending rib one 2313 and sealing bending rib two 2314) bend towards the center axis of the plugging head and converge, and finally converge to an anchoring support beam 31. This design can make the entire plugging sealing part 23 and its corresponding anchoring support beam 31 and anchoring converging part 36 form an integral whole, and can be formed at one time when the entire left atrial appendage plugging device is formed, thereby improving the overall flexible deformation performance. In particular, the sealing bending up part one 2311 of each sealing unit 231 converges with the sealing bending up part two 2312 of the adjacent sealing unit 231 at the top position of the sealing unit 231.

[0055] Meanwhile, the sealing bending up part two 2312 of each sealing unit 231 also converges with the sealing bending up part one 2311 of the adjacent sealing unit 231 at the top position of the sealing unit 231. This design can further enhance the connection strength of the entire plugging sealing part.

[0056] More preferably, the sealing bending rib one 2313 and the sealing bending rib two 2314 of the plurality of sealing units 231 bend towards the center axis of the plugging head and converge in the circumferential direction to form an anchoring top beam 40.

[0057] The width H in the height direction of the anchoring top beam 40 is reduced to improve the overall flexibility of the left atrial appendage plugging device, which is beneficial to improve the flexibility of this part of the structure, and then improve the compliance of the left atrial appendage plugging device to adapt to the left atrial appendage structures of different shapes.

[0058] As shown in Figure 1 , Figure 4 and Figure 5 , each anchoring support beam 31 is bifurcated and bent in the circumferential direction on the left and right sides near the converging part one end to form at least two bifurcated bending parts, i.e., bifurcated bending part one 32 and bifurcated bending part two 33. The bifurcated bending part one 32 and the bifurcated bending part two 33 respectively converge with the adjacent bifurcated bending part two 33 and the bifurcated bending part one 32 at the anchoring support point 34, and bend towards the inside of the axis to form an anchoring support part 35. The anchoring support part 35 bends and converges towards the inside of the axis and towards the direction of the plugging head to form an anchoring converging part 36. This design can enhance the flexible deformation resistance of the entire anchoring part 30 and increase the stability of the entire plugging device.

[0059] As shown in Figure 1 and Figure 4 , the top of each anchoring support part 35 is provided with an anchoring barb 37 in the reverse direction of the delivery tube. This design can enhance the positioning function of the entire anchoring part, can be recycled multiple times, has good flexibility, improves the anchoring of the plugging device in the left atrial appendage, and prevents the occurrence of falling off.

[0060] As Figure 1 and Figure 5 shown, the end of the anchoring converging part 36 is fixed as a whole by the inlay 39, avoiding the bottom tip structure to pierce the left atrial appendage wall when the occluder is delivered and placed, causing pericardial tamponade and other adverse symptoms. Figure 5 The embodiment shown is not welded with the inlay 39, and can also be realized, but the effect is slightly worse, but it is also within the protection scope of the present application.

[0061] From Figure 6 and Figure 7 embodiments, it can be seen that the bifurcated bending part one 32 and the bifurcated bending part two 33 of the plurality of anchoring support beams 31 form an anchoring bottom beam 50 in the circumferential direction, the width H in the height direction of the anchoring bottom beam 50 is reduced to improve the overall flexibility of the left atrial appendage occluder, which is beneficial to improve the flexibility of this part of the structure, and then improve the compliance of the left atrial appendage occluder to adapt to the left atrial appendage structure of different shapes.

[0062] A better embodiment can also be seen from the figure that the anchoring barb 38 in the delivery tube direction is a cross-shaped double barb structure, which is used to further improve its anchoring performance.

[0063] As Figure 8 shown, the plurality of anchoring support beams 31 are spiral structures, which are beneficial to improve the flexibility of the occluder up and down, and then can adapt to various different shapes of left atrial appendage structure, and have better adaptability.

[0064] The embodiments of the present application disclose the preferred embodiments, but are not limited thereto, and those skilled in the art can easily understand the spirit of the present application according to the above-mentioned embodiments, and make different inferences and changes, as long as they do not deviate from the spirit of the present application, they are within the protection scope of the present application.

Claims

1. An integrated left atrial appendage occluder, characterized by: The device comprises a sealing part (20) and an anchoring part (30) connected as a whole, wherein: The sealing part (20) is fixedly connected with the occlusion head (10) at one end and integrally formed with the anchoring part (30) at the other end, and has a sealing tension part (23) protruding from the anchoring part (30); The anchoring part (30) has an anchoring converging part (36) at the end, and has a plurality of anchoring support beams (31) symmetrically arranged with the center axis of the occlusion head (10) as the center line; The anchoring support beam (31) is provided with anchoring barbs (38) in the direction of the conveying pipe; The sealing part (20) comprises a fixed connection part (21), a sealing pre-bending part (22) and a sealing tension part (23) arranged in sequence from the occlusion head (10); The sealing tension part (23) is formed by a plurality of sealing units (231) arranged in a circle along the outside of the center axis of the occlusion head; Each of the sealing units (231) is bifurcated into at least one sealing bending and lifting part from the tail of the sealing pre-bending part (22) to both sides thereof; At least two sealing bending and lifting parts are respectively lifted towards the occlusion head, and then protrude outward from the center axis of the occlusion head by a distance and are bent inward to the center axis of the occlusion head to form at least a sealing bending rib; A plurality of sealing bending ribs are bent to the center axis of the occlusion head and converge on one anchoring support beam (31); The branch on one side of the sealing bending and lifting part of each of the sealing units (231) converges with the branch on one side of the sealing bending and lifting part of the adjacent sealing unit (231) at the top position of the sealing unit (231); the branch on the other side converges with the branch on one side of the sealing bending and lifting part of the adjacent sealing unit (231) at the top position of the sealing unit (231); Each of the anchoring support beams (31) is bifurcated and bent at the left and right sides in the circumferential direction at the end close to the converging part to form at least two bifurcated bending parts; Each of the bifurcated bending parts converges with the bifurcated bending part formed by the adjacent anchoring support beam (31) at the anchoring support point (34), is bent inward to the axial direction to form the anchoring support part (35), and is bent inward to the axial direction and towards the occlusion head to form the anchoring converging part (36); the top of each of the anchoring support parts (35) is provided with an anchoring barb (37) in the reverse direction of the conveying pipe; and the anchoring barb (38) in the conveying pipe direction is a cross-shaped double barb structure.

2. The integral left atrial appendage occluder according to claim 1, wherein: The sealing bending ribs of the plurality of sealing units (231) are bent to the center axis of the occlusion head and converge to form an anchoring top beam (40) in the circumferential direction; The width H in the height direction of the anchoring top beam (40) is reduced to improve the overall flexibility of the left atrial appendage occluder; The end of the anchoring converging part (36) is fixedly welded into a whole by a block (39).

3. The one-piece left atrial appendage occluder of claim 1, wherein: The forked bending parts of the plurality of anchor support beams (31) form an anchor bottom crossbeam (50) in the circumferential direction, and the width H in the height direction of the anchor bottom crossbeam (50) is reduced to improve the overall flexibility of the left atrial appendage occluder.

4. The one-piece left atrial appendage occlusion device of any of claims 1-3, wherein: The plurality of anchor support beams (31) are in a spiral structure.

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